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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

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THERAKOS CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Catalog Number CELLEX
Device Problem Air/Gas in Device (4062)
Patient Problems Pain (1994); Low Oxygen Saturation (2477); Cough (4457)
Event Date 10/23/2020
Event Type  Injury  
Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the oxygen that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2015.As part of the review, it was determined that the instrument's last service prior to the event was on 16-jan-2020.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Service was dispatched for the instrument.The service technician performed the system checkout procedure and found that all of the instrument's air detectors were working correctly.In addition, the service technician performed a water treatment, including inducing air alarms.The service technician verified that the instrument activated all air alarms appropriately, including when the collect line was removed from the water source.The root cause for the patient's cough, arm pain, and oxygen desaturation could not be determined based on the available information.Trends were reviewed for complaint categories cough, pain, and oxygen desaturation.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: cough, pain, and low oxygen saturation (b)(4); s.K.: (b)(6) 2020.
 
Event Description
The customer reported that an extracorporeal photopheresis (ecp) patient experienced coughing, arm pain and oxygen desaturation during a single needle mode ecp treatment procedure on (b)(6) 2020.The customer stated that at 300mls of whole blood processed, the patient experienced coughing and pain in his arm.The customer reported that she checked both the patient's peripheral iv access and the cellex photopheresis kit's ("kit") lines and noticed air in both the kit's collect and return lines.The customer stated that the air in the kit's collect and return lines was already past the instrument's air detectors.The customer reported that no alarms had occurred.The customer stated that the patient's ecp treatment procedure was then aborted.The customer reported that the patient was placed on his side, and two liters of oxygen was administered to the patient due to his oxygen saturation dropping to 91%.The customer stated that the emergency response team was called and they assessed the patient as stable.The customer reported that the patient felt fine after the administration of the two liters of oxygen and the patient was now stable.The customer stated that it was unknown if any air had reached the patient.The customer reported that the patient's physician decided that the patient was well enough to undergo a second ecp treatment procedure that day using a different instrument.The customer stated that the patient's second ecp treatment procedure was successfully completed.The customer reported that the instrument had been placed out of use pending service.The customer stated that both the kit and smartcard had been discarded.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM
Manufacturer (Section D)
THERAKOS
bedminster NJ
Manufacturer (Section G)
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
college business & tech park
cruiserath road
blanchardstown, dublin D15 T X2V
EI   D15 TX2V
Manufacturer Contact
megan vernak
1425 us route 206
bedminster, NJ 07921
MDR Report Key10871945
MDR Text Key219310778
Report Number2523595-2020-00124
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCELLEX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/23/2020
Initial Date FDA Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight81
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